Trial · NCT00423592
Phase 2 Study of Ambrisentan for Liver Function Test Rescue in Pulmonary Arterial Hypertension
NCT00423592, Phase 2, Completed, Gilead Sciences; results first posted 2012-06-20
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Phase 2 Study of Ambrisentan for Liver Function Test Rescue in Pulmonary Arterial Hypertension. Trials, record NCT00423592. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00423592
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 2 Study of Ambrisentan for Liver Function Test Rescue in Pulmonary Arterial Hypertension
- NCT number
- NCT00423592
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 36 participants, actual
- Lead sponsor
- Gilead Sciences
- Conditions
- Pulmonary Hypertension
- Interventions
- ambrisentan
- First posted
- 2007-01-18
- Last updated
- 2013-06-17
- Results first posted
- 2012-06-20
- Limitations and caveats
Seven subjects were excluded from the change from baseline analysis of the SF-36 Health Survey because the incorrect version of the SF-36 questionnaire was used for evaluation at baseline, which made comparisons problematic.
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Incidence of Confirmed Serum Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) Concentrations > 3 x the Upper Limit of Normal (ULN) Considered to be Related to Ambrisentan and Resulted in Discontinuation of Study Drug. | Week 12 | The number of participants in the safety analysis set with confirmed serum ALT or AST concentrations \> 3 x ULN during 12 weeks of ambrisentan therapy that were related to ambrisentan and resulted in discontinuation of study drug. Safety analysis set included all participants who received at least 1 dose of study drug. |
| Secondary | The Incidence of Confirmed Serum ALT or AST Concentrations > 5 x ULN That Were Related to Ambrisentan and Resulted in Discontinuation of Study Drug. | Week 12 | The number of participants in the safety analysis set with confirmed serum ALT or AST concentrations \> 5 x ULN during 12 weeks of ambrisentan therapy that were related to ambrisentan and resulted in discontinuation of drug. Safety analysis set included all participants who received at least 1 dose of study drug. |
| Secondary | The Incidence of Confirmed Serum ALT or AST Concentrations > 3 x ULN That Were Related to Ambrisentan and Resulted in Dose Reduction | Week 12 | The number of participants in the safety analysis set with confirmed serum ALT or AST concentrations \> 3 x ULN during 12 weeks of ambrisentan therapy that were related to ambrisentan and resulted in dose reduction. Safety analysis set included all participants who received at least 1 dose of study drug. |
| Secondary | A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in the 6-Minute Walk Distance Test (6MWD) | Baseline to Week 12 | The 6MWD test is a measure of exercise tolerance, and measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. |
| Secondary | A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in Borg Dyspnea Index Immediately Following Exercise | Baseline to Week 12 | Change from baseline evaluated after 12 weeks of ambrisentan therapy in Borg dyspnea index (measured as units on a scale) immediately following exercise. Borg Dyspnea Index, a measure of perceived shortness of breath: 0 units on a scale (none) to 10 units on a scale (maximum breathlessness). |
| Secondary | A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in WHO Functional Class | Baseline to Week 12 | Classes: I) pulmonary hypertension (PH); ordinary physical activity not limited or causes undue dyspnea or fatigue, chest pain, or near syncope. II) PH; ordinary physical activity slightly limited and causes undue dyspnea or fatigue, chest pain, or near syncope; comfortable at rest. III) PH; physical activity markedly limited and less than ordinary physical activity causes undue dyspnea or fatigue, chest pain, or near syncope; comfortable at rest. IV) PH; physical activity causes symptoms and increased discomfort; signs of right heart failure; dyspnea/fatigue possibly at rest. |
| Secondary | A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in Short Form 36 (SF-36) Health Survey Scale - Composite Physical Health | Baseline to Week 12 | The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). The first 6 concepts constitute the physical component summary. Each item is scored from 0 to 100 (least healthy to most healthy). |
| Secondary | Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Composite Mental Health | Baseline to Week 12 | The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). The last 5 concepts constitute the mental component summary. Each item is scored from 0 to 100 (least healthy to most healthy). |
| Secondary | Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Physical Functioning | Baseline to Week 12 | The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). Each item is scored from 0 to 100 (least healthy to most healthy). |
| Secondary | Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Role Physical | Baseline to Week 12 | The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). Each item is scored from 0 to 100 (least healthy to most healthy). |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Incidence of Confirmed Serum Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) Concentrations > 3 x the Upper Limit of Normal (ULN) Considered to be Related to Ambrisentan and Resulted in Discontinuation of Study Drug. | Week 12 | The Safety analysis set was defined as all subjects who received at least 1 dose of study drug. All subjects who received at least 1 dose of ambrisentan were followed (to the extent possible) to the end of the study and included in the analyses of safety. | Participants | NUMBER |
| SECONDARY | The Incidence of Confirmed Serum ALT or AST Concentrations > 5 x ULN That Were Related to Ambrisentan and Resulted in Discontinuation of Study Drug. | Week 12 | The Safety analysis set was defined as all subjects who received at least 1 dose of study drug. All subjects who received at least 1 dose of ambrisentan were followed (to the extent possible) to the end of the study and included in the analyses of safety. | participants | NUMBER |
| SECONDARY | The Incidence of Confirmed Serum ALT or AST Concentrations > 3 x ULN That Were Related to Ambrisentan and Resulted in Dose Reduction | Week 12 | The Safety analysis set was defined as all subjects who received at least 1 dose of study drug. All subjects who received at least 1 dose of ambrisentan were followed (to the extent possible) to the end of the study and included in the analyses of safety. | participants | NUMBER |
| SECONDARY | A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in the 6-Minute Walk Distance Test (6MWD) | Baseline to Week 12 | The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value. | meters | MEAN |
| SECONDARY | A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in Borg Dyspnea Index Immediately Following Exercise | Baseline to Week 12 | The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value. | Units on a scale | MEAN |
| SECONDARY | A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in WHO Functional Class | Baseline to Week 12 | The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value. | Participants | NUMBER |
| SECONDARY | A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in Short Form 36 (SF-36) Health Survey Scale - Composite Physical Health | Baseline to Week 12 | The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value. | Units on a scale | MEAN |
| SECONDARY | Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Composite Mental Health | Baseline to Week 12 | The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value. | Units on a scale | MEAN |
| SECONDARY | Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Physical Functioning | Baseline to Week 12 | The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value. | Units on a scale | MEAN |
| SECONDARY | Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Role Physical | Baseline to Week 12 | The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value. | Units on a scale | MEAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
The Incidence of Confirmed Serum Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) Concentrations > 3 x the Upper Limit of Normal (ULN) Considered to be Related to Ambrisentan and Resulted in Discontinuation of Study Drug. | Ambrisentan | 0 | Participants | ||
| The Incidence of Confirmed Serum ALT or AST Concentrations > 5 x ULN That Were Related to Ambrisentan and Resulted in Discontinuation of Study Drug. | Ambrisentan | 0 | participants | ||
| The Incidence of Confirmed Serum ALT or AST Concentrations > 3 x ULN That Were Related to Ambrisentan and Resulted in Dose Reduction | Ambrisentan | 0 | participants | ||
| A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in the 6-Minute Walk Distance Test (6MWD) | Ambrisentan | 23.4 | Standard Deviation 49.60 | meters | |
| A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in Borg Dyspnea Index Immediately Following Exercise | Ambrisentan | -0.5 | Standard Deviation 1.51 | Units on a scale | |
| A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in WHO Functional Class | Ambrisentan | Improved | 15 | Participants | |
| A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in WHO Functional Class | Ambrisentan | No Change | 18 | Participants | |
| A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in WHO Functional Class | Ambrisentan | Deteriorated | 2 | Participants | |
| A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in Short Form 36 (SF-36) Health Survey Scale - Composite Physical Health | Ambrisentan | 4.6 | Standard Deviation 6.44 | Units on a scale | |
| Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Composite Mental Health | Ambrisentan | 3.4 | Standard Deviation 8.98 | Units on a scale |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ambrisentan | 36 | |
| Overall Study | Completed Preliminary Analysis Cut-off | Ambrisentan | 34 | |
| Overall Study | COMPLETED | Ambrisentan | 29 | |
| Overall Study | NOT COMPLETED | Ambrisentan | 7 |
Source ClinicalTrials.gov
Adverse events132
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | anaemia | Blood and lymphatic system disorders | Ambrisentan | 8 | 36 | |
| other | lymphadenopathy | Blood and lymphatic system disorders | Ambrisentan | 2 | 36 | |
| other | atrial fibrillation | Cardiac disorders | Ambrisentan | 4 | 36 | |
| other | bradycardia | Cardiac disorders | Ambrisentan | 2 | 36 | |
| other | coronary artery disease | Cardiac disorders | Ambrisentan | 2 | 36 | |
| other | palpitations | Cardiac disorders | Ambrisentan | 8 | 36 | |
| other | tricuspid valve incompetence | Cardiac disorders | Ambrisentan | 3 | 36 | |
| other | vertigo | Ear and labyrinth disorders | Ambrisentan | 3 | 36 | |
| other | conjunctival haemorrhage | Eye disorders | Ambrisentan | 2 | 36 | |
| other | vision blurred | Eye disorders | Ambrisentan | 2 | 36 |
1 to 10 of 132Source ClinicalTrials.gov
See all 132 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ambrisentan | ||
| Total, other adverse events | Ambrisentan | 36 | 36 |
| Total, serious adverse events | Ambrisentan | 17 | 36 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 18812445 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00423592
GET https://conductscience.org/api/trials/v1/NCT00423592/events?page=2